A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/21/2019 |
| Start Date: | November 5, 2017 |
| End Date: | May 31, 2018 |
A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Two Concentrations (0.10%, 0.25%) of HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
The objective of this study is to compare the safety and efficacy of 0.10% and 0.25% HL036
Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Inclusion Criteria:
- Have a patient-reported history of dry eye for at least 6 months prior to enrollment
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
of Visit 1
- Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2
Exclusion Criteria:
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
ocular inflammation at Visit 1
- Have used Restasis® or Xiidra® within 60 days of Visit 1
- Be currently taking any topical ophthalmic prescription (including medications for
glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and
cannot discontinue these medications for the duration of the trial (excluding
medications allowed for the conduct of the study)
- Have an uncontrolled systemic disease
- Be a woman who is pregnant, nursing or planning a pregnancy
We found this trial at
1
site
Click here to add this to my saved trials
